Job Description
Job Duties/Responsibilities:
Oversight / Project Management.
- Understands the vendor management framework set by the Head of MAP & Safety Partnering and translates the requirements into reporting deliverables (e.g., QA/QC metrics, action items, etc.) * Works with the Vendor Lead on the oversight of GVP/MAP SPs.
- Supports the Vendor Lead on all operations performed, including the implementation of policies/procedures that ensure efficient and compliant operations.
- Ensures quality and PV requirements are met in accordance with contractual obligations.
- Facilitates and participates in SP oversight activities such as SP meetings.
- Develops agenda and facilitates meetings with SP.
- Tracks statuses for critical milestones and metrics.
- Creates action items and follow-ups on action items.
- Appropriately escalates to MAP Management Team and Vendor Lead as required.
- Communicates closely with local cross-functional teams within US PS to ensure the appropriate level of support is achieved to ensure oversight.
- Determines priorities and resource load balancing to manage backlogs, action items, and business as usual.
- Leads, coordinates, and collates QC error rates, QC metrics, trends, and gaps for the MAP Management and Vendor Lead.
- Leads or assists in the tracking and investigation of case processing-related metrics (e.g., late case investigation) including compliance-related issues set by the vendor management strategy.
- Understands the PV environment and works with Vendor Lead and Head of MAP and Safety Partnering to identify SP compliance risks.
Monitoring Performance.
- Monitors SP compliance to applicable SOPs and Key Performance Indicators as detailed in the Service Agreement and global/local requirements.
- Oversees Corrective and Preventative Actions by the SP, as required.
- Supports MAP management and Vendor Lead during audits and inspections.
Issue / Risk Management.
- Acts as a day-to-day point of contact with US PS SPs and ensures strong relationships and communication are built between GNE and the SP. Acts as a point of inquiry for any questions/concerns raised by the SP with appropriate resolution or escalation by Roche/GNE
- Provides regular feedback on performance and quality checks to the SP working together with MAP Management and Vendor lead.
- Working together with the MAP Management and Vendor Lead communicates any processes or procedural changes.
- Escalates any critical decisions or discussions to the Vendor Lead and Head of MAP & Safety Partnering. * Provides support to MAP Management and Vendor Lead by answering questions on Vendor Management reports and deliverables.
- Escalates SP risks to the Vendor Lead and MAP Management as required.
- Actively identifies process improvement opportunities, gaps, and risks and communicates to MAP Management and Vendor Lead to support continuous quality improvement.
Skills:
- Exemplifies strong, dynamic leadership and demonstrates decisiveness and appropriate decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, prioritization of tasks in a timely manner within the scope of responsibility, and escalates identified issues to management in a timely fashion.
- Works effectively, independently, and collaboratively as a team member with global stakeholders and external business partners
- Strong organizational skills, detail-oriented, and adapts to a fast-paced, changing environment
- Demonstrates ownership, initiative, accountability, strong organizational skills, and is solution-oriented
- Excellent communication skills, both written and verbal
- Ability to actively exchange knowledge and ideas
- Able to identify potential business gaps and leads in the development and implementation of process solutions
- Able to handle the pressure associated with and adapts to a fast-paced, changing environment
- Demonstrates ownership, initiative, accountability, strong organizational skills, and is solution-oriented Inspires others to do their best work by offering encouragement and support
- Maintains personal and corporate integrity
Education:
- Life sciences degree BSc minimum (or 10 years experience in a similar role) with 5+ years in pharmacovigilance or compliance-related role required
- Advanced analytic and computer skills (e.g., Microsoft Excel, other data visualization tools) preferred
- Medical terminology experience preferred
- Writing experience; science/medical writing highly desirable
- Able to travel as per business needs required
- Able to be agile and adapt to shifting priorities and needs
- Able to be flexible to accommodate differences in vendor time zones
Pay Rate Range: 30-40/hr depending on experience
Job Tags
Remote job, Contract work, Local area, Flexible hours, Shift work,